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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05744128
Other study ID # IAB-CD8-204
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date February 16, 2023
Est. completion date December 15, 2025

Study information

Verified date March 2024
Source ImaginAb, Inc.
Contact Bronwen Williams
Phone +44 (0) 1482 462771
Email Bronwen.Williams@hyms.ac.uk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Zr-89 crefmirlimab berdoxam is a Zirconium-89 labelled minibody developed by ImaginAb for full body PET imaging of CD8+ cell distribution (CD8 ImmunoPET). The primary objective of this study is to assess the test-retest repeatability of CD8 immunoPET imaging in oncology patients with stable disease.


Recruitment information / eligibility

Status Recruiting
Enrollment 12
Est. completion date December 15, 2025
Est. primary completion date December 15, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Aged 18 years and above - Patients with at least one imageable primary or metastatic lesion > 1 cm in the lymph nodes or soft tissue excluding bone on the most recent standard of care imaging done within the last 3 months - Cohort 1: Patients with melanoma on single or multiple agent Immune Checkpoint Blockade (ICB) therapy with stable response status following initiation of therapy. Stable disease would be observed over at least 2 consecutive standard of care CT scans (usually done 8-12 weeks apart) after initiation of therapy. - Cohort 2: Patients with untreated renal cell carcinoma on active surveillance - Women of child bearing potential must not be pregnant on study entry - Participants must agree to follow contraceptive advice while on study and for 30 days after ending participation. Exclusion Criteria: - Patients with uncontrolled infection or other concurrent malignancies or conditions that may confound interpretation of the scans in the opinion of the investigator - Patients with urinary catheters or stoma bags - Patients who have received a vaccine recently can be included to the study but can only be scanned after a washout period of 2 weeks after the vaccine. If participants have a vaccine after the first PET-CT scan, the second PET-CT scan will be delayed for at least 2 weeks after the vaccine - Patients on steroids except those on replacement dose of steroids for adrenal or pituitary insufficiency. Patients requiring steroids as therapy for an unresolved immune therapy related adverse event will be excluded - Participants on immunosuppressive medication e.g. cyclosporine, azathioprine, janus kinase inhibitors - Participant enrolled into another therapeutic intervention study - Any other contraindication that makes the patient unsuitable to take part in the study in the opinion of the investigator - Women who are pregnant or breast feeding - Unable to provide informed consent

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Zirconium 89Zr crefmirlimab berdoxam
Zirconium-89 labelled minibody for whole body PET imaging to visualize CD8+ cell distribution.

Locations

Country Name City State
United Kingdom Castle Hill Hospital Hull

Sponsors (2)

Lead Sponsor Collaborator
ImaginAb, Inc. University of Hull

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary SUVs in tumor Absolute and relative difference in tumor SUVs 2-4 weeks
Primary SUVs in reference tissues Absolute and relative difference in reference tissue SUVs 2-4 weeks
Primary ratio of tumor SUVs to reference tissue SUVs Absolute and relative difference in SUV ratios 2-4 weeks
Secondary Safety of repeat doses of Zr-89 crefmirlimab berdoxam Adverse events collected during the trial and as self-reported events. Through study completion, an average of 8 weeks
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